Healthy
Conditions
Keywords
Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Infliximab, Healthy Volunteers, Single-dose, Immunology
Brief summary
In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.
Interventions
BIOLOGICALPF-06438179
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
BIOLOGICALRemicade
Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). * Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight \>50kg (110 lbs).
Exclusion criteria
* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Previous exposure to a monoclonal antibody, or current use of other biologics. * History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs. * History of tuberculosis (TB) or a positive latent TB test at Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day 1 - Day 57 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) | Day 1 - Day 57 |
| Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) | Day 1 - Day 57 |
Secondary
| Measure | Time frame |
|---|---|
| Systemic Clearance (CL) | Day 1 - Day 57 |
| Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab) | Day 1 - LSLV or Day 85 whichever occurs later |
| Terminal Disposition Half-Life (t1/2) | Day 1 - Day 57 |
| Volume of Distribution at Steady State (Vss) | Day 1 - Day 57 |
Countries
United States
Outcome results
None listed